New EPA standards to reduce ethylene oxide emissions

Editor's Note

New standards from The Environmental Protection Agency promise to cut nationwide emissions of ethylene oxide—employed to sterilize more than half of US medical devices—by more than 90 percent.

According to a March 15 MedPage Today report, the aim is to reduce cancer risk among the 13 to 14 million people estimated to live near commercial sterilization facilities, “which are often situated in low-income communities and communities of color."

Citing an EPA fact sheet, the article describes the short- and long-term risks (particularly to children) and notes that the EPA revises toxic air standards every 8 years to comply with the Clean Air Act. Motivated by changes in scientific understanding of ethylene oxide’s health effects, the resulting rule was informed by “extensive outreach” to communities and aims to balance safety with the need for “a safe and reliable supply of medical sterilization devices.”

The final rule, expected to effect 90 commercial sterilizers owned by 50 companies, results in the following amendments to the national Emission Standards for Hazardous Air Pollutants:

• Creating standards for currently unregulated emissions
• Strengthening standards for sources of ethylene oxide
• Additional mandates for emission monitoring and reporting
• Enforcing emission standards during startup, shutdown, and malfunction at sterilization facilities

According to MedPage, the FDA has  been encouraging alternatives to ethylene oxide, including a recent announcement of vaporized hydrogen peroxide as an established sterilization method for medical devices.